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HeartStart MRx Defibrillator Recalled for Defective Part

The United States Food and Drug Administration (FDA) recently issued a recall for the Philips HeartStart MRx defibrillator because it contains a faulty part that can put patients at risk of serious injury and death.

The defective medical device was recalled after it was determined that a glass tube inside the defibrillator has tiny cracks that allow gases to escape and cause the device to malfunction. These cracks also allow electrical surges to cross the defibrillator's resistors, potentially damaging them and causing the device to fail while it is in automated external defibrillator (AED) mode. When the device fails in this mode, it can still be operated manually. Healthcare providers who have the defibrillator are urged to have the defective glass tube repaired to prevent patient injuries and deaths. In their uncorrected state, these defibrillators can fail at any time.

When a patient is injured by a defective medical device, he or she may seek compensation for his or her damages through a defective medical device claim. When a victim dies from a defective medical device, his or her loved ones may seek compensation for damages through a wrongful death claim.

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It has been several years since Michigan-based medical device manufacturer Stryker issued a voluntary recall of their Rejuvenate and ABH II modular-neck stem metal hip replacements, according to the U.S. Food and Drug Administration. The recall was made after many patients complained that the hip replacement was defective, causing them more pain and suffering than before the implant was surgically inserted. The main issue with the device is that it was found to be subject to a high rate of corrosion at the neck junction.

In November of last year, an agreement was reached in New Jersey that determined that the manufacturer would pay an average of $300,000 per implant in individual lawsuits brought against it. In some cases, depending if the patient is deceased, the payout may be less. In other cases, in which the pain and suffering is determined to be extreme, the payout may be more. The company, in total, would payout $1.4 billion in settlement claims, though the claim must be filed by an individual patient, even in this mass tort case.

If you have experienced pain or suffering because of a Stryker hip implant, the first step is to seek legal counsel. The next is to enroll in the Settlement Program. Enrollment opened on January 16 of this year, and is open until March 2. If you do not enroll in the Settlement Program before March 2, you will not be eligible to receive compensation. The fact that you enrolled in the claims process, however, does not guarantee that you will receive payment either. If you did not register for the settlement by December of last year, it is possible that you are not eligible to enroll. If this is the case for you, it is imperative that you speak with an attorney right away.

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In what will likely be the first of many settlements to come, Johnson & Johnson has agreed to resolve claims from four Missouri women that its Ethicon Prolift vaginal mesh implant caused serious injuries.

The settlements came almost literally at the courthouse door, as jury selection was scheduled to begin in late January 2015. Since the controversy over these devices began in 2012, J&J consistently denied that these devices are dangerous. Nevertheless, it currently faces about 23,000 liability lawsuits. One observer noted that “it's only four cases, but it's a start. There's still a long way to go to get the whole thing resolved.” A J&J spokesperson emphasized that the company did not admit or deny liability as part of the settlement terms and that “the company may consider whether settlement is appropriate” in individual cases.

Johnson and Johnson voluntarily recalled the Ethicon Prolift in June 2012, along with three other vaginal mesh implants. Other manufacturers include Boston Scientific, American Medical Systems and Coloplast.

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Lupron is a hormonal regulator that has several dangerous, if not oft-publicized side effects of which every patient should be aware. The drug is prescribed to help slow early-onset puberty in teenagers, to men who exhibit signs of prostate cancer, and to help treat women with endometriosis, a rare condition in which the lining of the uterus grows outside the actual uterus. According to the U.S. Food and Drug Administration (FDA), the first adverse reaction to Lupron was discovered in 2012, after marketing of the drug had already began, and consisted of a rarely-reported complication of the liver. Six months later, the FDA reported that Lupron could result in lung complications and disease, and one year later, the FDA found serious complications of the drug that could lead to liver injury or convulsions, such as those experienced by patients who suffer from epilepsy.

Most patients take Lupron in the form of a daily shot, according to WebMD. In children, dosage is based on weight and what type of therapy for which the drug is being administered. One easy test to see if the drug is defective is to check the liquid for particles or discoloration, according to WebMD. The site of the injection should be changed periodically, so as not to overload one particular area with too much of the drug at any given time.

Regardless of where or how it is injected, however, Lupron can have deadly side effects. According to Wellsphere.com, one doctor advised that the drug should be pulled from the market as early as 2008. The doctor alleged that the manufacturing company of Lupron did not adequately study the possible side effects of the drug before approving it for consumer use. In 2009, the pharmaceutical company agreed to pay $875 million “to settle claims that it paid kickbacks to doctors to promote Lupron,” Wellsphere.com reports. More than 12,000 reports of Lupron's negative side effects have been reported to the FDA, resulting in more 1,100 deaths.

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The U.S. Food and Drug Administration (FDA) issued its largest recall of medical products ever in 2014, according to the Regulatory Affairs Professional Society (RAPS). The recall, posted to the FDA's website in August, was of 233 Class I products manufactured by Puerto Rico-based Customed.

The FDA classifies medical devices and products into three categories: Class I have the least potential to harm a user—Class III products are usually those that sustain life. Class I examples can include bandages, enema kits, and any medical product not necessary to keep a person's vital organs functioning. Nearly half of all medical products on the market are classified into Class I, according to the FDA.

The devices recalled by Customed were recalled because of packaging flaws. The products were primarily sterile convenience packs; the recall was initiated because of “adhesion in the sterile packaging,” according to RAPS. If the product was used on a patient, it had the potential to not be sterile and lead to infection, though as of September, no cases had been discovered of a person suffering an infection or side effects because of Customed products. The FDA generally does not wait until a case of injury has been discovered to recall medical products; once the manufacturer is aware of the problem, it is responsible to initiate a recall immediately.

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